DOUBLE WEAR STAY IN PLACE SPF 10 MAKEUP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

ESTEE LAUDER

DOUBLE WEAR

STAY-IN-PLACE POWDER MAKEUP

SPF 10

NET WT. 0.42 OZ/ 12 g

Estee Lauder Dist.New York, NY 10022

DOUBLE WEAR
STAY IN PLACE SPF 10 MAKEUPtitanium dioxide powder

Product Information

Product Type

HUMAN OTC DRUG

Item Code (Source)

NDC:11559-729

Route of Administration

TOPICAL

DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Strength

TITANIUM DIOXIDE (TITANIUM DIOXIDE)

TITANIUM DIOXIDE

4.0 g in 100 g

Inactive Ingredients

Ingredient Name

Strength

TALC

SILICON DIOXIDE

CALCIUM SILICATE

BORON NITRIDE

PHENYL TRIMETHICONE

POLYMETHYLSILSESQUIOXANE (11 MICRONS)

CAPRYLYL GLYCOL

ALUMINUM HYDROXIDE

HEXYLENE GLYCOL

PHENOXYETHANOL

FERRIC OXIDE RED

MICA

CHROMIC OXIDE

COCHINEAL

BISMUTH OXYCHLORIDE

Packaging

#

Item Code

Package Description

1

NDC:11559-729-01

1 JAR (JAR) in 1 CARTON

1

NDC:11559-729-02

12 g in 1 JAR

Marketing Information

Marketing Category

Application Number or Monograph Citation

Marketing Start Date

Marketing End Date

OTC monograph not final

part352

03/01/2007

Labeler - ESTEE LAUDER INC
(005914387)

Establishment

Name

Address

ID/FEI

Operations

ESTEE LAUDER COSMETICS, LTD

205952385

manufacture

Establishment

Name

Address

ID/FEI

Operations

ESTEE LAUDER N.V.

370151326

manufacture

Establishment

Name

Address

ID/FEI

Operations

Len-Ron Manufacturing Division of Aramis Inc.

809771152

manufacture

Establishment

Name

Address

ID/FEI

Operations

Aramis Inc.

042918826

manufacture

Establishment

Name

Address

ID/FEI

Operations

Northtec Bristol

949264774

manufacture, relabel, repack

Establishment

Name

Address

ID/FEI

Operations

Northtec Keystone

618107429

manufacture, relabel, repack

Establishment

Name

Address

ID/FEI

Operations

Estee Lauder Pennsylvania Distribution Center 2

828534516

manufacture, relabel, repack

Establishment

Name

Address

ID/FEI

Operations

Estee Lauder Cosmetics, Ltd.

255175580

manufacture

Establishment

Name

Address

ID/FEI

Operations

Estee Lauder Cosmetics, Ltd

253616536

manufacture

Establishment

Name

Address

ID/FEI

Operations

Estee Lauder Cosmetics Distribution Center

208579636

repack, relabel

Establishment

Name

Address

ID/FEI

Operations

Estee Lauder Kabushiki Kaisha

712808195

relabel, repack

Establishment

Name

Address

ID/FEI

Operations

Whitman Laboratories Ltd.

216866277

manufacture

Establishment

Name

Address

ID/FEI

Operations

Aveda Corporation

071352058

manufacture

Revised: 10/2011

Document Id: d35449cf-3329-4773-980d-4230a255feae

Set id: 33587c55-12a6-4312-bb1c-034d43835837

Version: 1

Effective Time: 20111004

ESTEE LAUDER INC

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